经验分享|FDA官网常用检索指南图解(三)橙皮书+特殊产品开发指南+批准信息查询

本文汇总了新版FDA网站常用数据检索途径,旨在能帮助大家更快使用新版FDA网站,提高文献检索工作效率。

5、 橙皮书

点击“图1”中“Orange Book”进入橙皮书检索页“图2”。网址:https://www.accessdata.fda.gov/s/cder/ob/index.cfm,可按下图方式检索。

https://www.qacren.com/uploads/article/20191107/6da5c35b27056f2c032a61da05181f77.jpeg

图1

/uploads/article/20191107/40efa3376fe12629ef48ef0ab3a874fa.jpeg

图2

以“阿哌沙班片”为例,在精确检索栏输入“apixaban”,弹出批准列表。如“图3”

/uploads/article/20191107/24719bf7fea7b1ecfc91f06df93bde41.jpeg

图3

点击“图3”中批准号“Appl No.”进入下图“图4”

/uploads/article/20191107/b66786dfd53729a7ef7bcf3e238570c6.jpeg

图4

点击“图4”中“Patent and Exclusivity Information”,检索到原研专利号。

/uploads/article/20191107/e5a08a5464e33b7f54a17b5836b42072.jpeg

图5

6、特殊产品开发指南

点击“图3”中“Product-Specific Guidances for Generic Drug Development”,进入检索页,网址:https://www.accessdata.fda.gov/s/cder/psg/index.cfm?event=Home.Letter&searchLetter=A#letterSearchBar,精确查找或模糊查找。

/uploads/article/20191107/f87433b1bcdf558af6f2b4c58981a58f.jpeg

图6

以“abiraterone”为例,查找药物BE指导原则草案,如“图7”。

/uploads/article/20191107/ba204aef4712875784565152ae0622bb.jpeg

图7

7、批准信息查询

点击“图1”中左侧“Resources for Information on Approved Drugs”进入药物批准信息查询页面。网址:https://www.fda.gov/drugs/how-drugs-are-developed-and-approved/drug-and-biologic-approval-and-ind-activity-reports

/uploads/article/20191107/cc4e2622c6536a550012e553fd6e3e3c.jpeg

图8

点击“图8”中“Drug and Biologic Approval and IND Activity Reports”,检索药物批准信息。

/uploads/article/20191107/9e7905866f2ed2b59bd12e22d4e65157.jpeg

图9

点击“图9”中“NDA and BLA Approvals”,网址:https://www.fda.gov/drugs/nda-and-bla-approvals/nda-and-bla-calendar-year-approvals,按“图10”查询NDA和BLA(生物药)批准信息。

/uploads/article/20191107/4a4bfcd79ee0ee0a0a3f376cdacce079.jpeg

图10

点击 “NDA and BLA Calendar Year Approvals”,在下载页,如“图11”所示,列表中“Y”代表按505(b)(2)途径申报的新药。

/uploads/article/20191107/1416e6c174208f8e85fb60cbc2735226.jpeg

图11






0 个评论

要回复文章请先登录注册